MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR "ESG-410"; WA91307C

Model Number	WA91307C
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during sedation of a therapeutic cystoscopy the generator had the incorrect quick reference guide.This caused a surgical prolongation greater than 30 minutes and the procedure was completed using a competitor device.There were no reports of patient harm.
Additional Manufacturer Narrative
The event was conservatively classified as a serious injury due to the procedure allegedly being prolonged by 30 or more minutes.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.This report has been submitted by the importer under this mdr report number 2429304-2025-00073.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction and the results of the investigation.Updated fields: h2 and h6.Corrections to: b1, b2, e1 and h1.This event was initially conservatively reported as a serious injury; however, there is no evidence the patient suffered any serious injury or adverse effects from the prolonged procedure.Olympus made multiple attempts to receive more information from the customer without success.Thus, correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.The h6 medical device problem reported would not cause or contribute to a death or a serious injury if it were to recur.The device was not returned to olympus for inspection; however, technical assistance center (tac) provided remote troubleshooting.The issue is that the customer's quick reference guide is not the same as the image for the settings menu on the device.Furthermore, tac consulted with lead tech, and mentioned that there are two esg-410s, one hybrid and one that is not.Tac has not received an update from facility.A definitive root cause of the reported issue could not be determined.Based on the results of the investigation, the most probable cause of the complaint is cause not established which the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-410"
• Common Device Name: WA91307C
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21356076
• Report Number: 3003724334-2025-00046
• Device Sequence Number: 20754391
• Product Code: GEI
• UDI-Device Identifier: 04042761086349
• UDI-Public: 04042761086349
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WA91307C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown